Effect on Pain and Comfort Associated With Fistula Puncture

NCT ID: NCT05574595

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2022-11-15

Brief Summary

Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis.

Material and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. By block randomization method to randomize. Data were collected with "Patient identification formula", "Visual Analog Scale (VAS)" and "Hemodialysis Comfort Scale". Independent sample t-test was used in the analysis of the data, analysis of variance in repeated measurements and Cohen'd was used to calculate the size.

Detailed Description

It is appropriate to suggest a non-pharmacological rather clinical rather than a literature-free method, al. Also, due to the fact that the duration of anesthetic effect will expire from the dialysis treatment used (Subramanian et al., 2012).

Participant's care continues for inappropriate pain management. This quality standard is one of the criteria of a standard rather than a preference for a simple, reliable and inexpensive non-pharmacological choice.

As far as investigators know, there are very few studies investigating the effect of a patient's choice of music on pain following insertion of a needle into a fistula in hemodialysis patients. More focused on non-pharmacological types such as pharmacological and aromatherapy. Therefore, the aim of this study was to examine the effect of the type of music chosen by hemodialysis patients on pain and comfort associated with fistula puncture.

Conditions

Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients

To the Experimental Group; The information form and the short form of the comfort scale will be applied to the patient who is taken to the dialysis unit to start HD treatment.

Group Type: EXPERIMENTAL

Music theraphy

Intervention Type: OTHER

In each session, the desired type of music will be played approximately 6 minutes before the procedure (Shabandokht-Zarmi et al., 2017). After the end of the music, the cannulation process will be performed by the dialysis nurse. The level of pain experienced by the patient immediately after needle insertion into the fistula will be evaluated with VAS by a research-independent nurse working in the dialysis unit.

The mean of the Hemodialysis Comfort Scale scores of the control group patients

No procedure was performed on the patients in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music theraphy

In each session, the desired type of music will be played approximately 6 minutes before the procedure (Shabandokht-Zarmi et al., 2017). After the end of the music, the cannulation process will be performed by the dialysis nurse. The level of pain experienced by the patient immediately after needle insertion into the fistula will be evaluated with VAS by a research-independent nurse working in the dialysis unit.

Intervention Type: OTHER

Other Intervention Names

There is no other name.

Eligibility Criteria

Inclusion Criteria

• be volunteering,
• 18 years or older,
• receiving hemodialysis treatment for at least 6 months
• not any hearing problem.

Exclusion Criteria

• have hearing problem
• not be volunteering.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kırklareli University

OTHER

Sponsor Role: lead

Responsible Party

Aylin Aydin Sayilan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurşen KULAKAÇ, pHD

Role: PRINCIPAL_INVESTIGATOR

Gümüşhane Universıty

Central Contacts

Aylin AYDIN SAYILAN, PhD

Role: CONTACT

aylin.sayilan@klu.du.tr

+902882145547

References

Sayilan S, Sayilan AA, Kulakac N. The effect of self-selected soothing music on fistula puncture-related pain and comfort levels in hemodialysis patients: a randomized controlled, single-blind, single-center study. Int Urol Nephrol. 2025 Oct 28. doi: 10.1007/s11255-025-04877-5. Online ahead of print.

Reference Type: DERIVED

PMID: 41148531 (View on PubMed)

Other Identifiers

2022/4

Identifier Type: -

Identifier Source: org_study_id